Events

Retiro De Equipo (Recall) de Device Recall SenDx Medical Inc. ABL80FLEX

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Sendx Medical Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    61178
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1384-2012
  • Fecha de inicio del evento
    2012-01-30
  • Fecha de publicación del evento
    2012-04-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107472
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Causa
    The product can cause the analyzer to report values outside the published performance specifications for ph, pco2, cna+, ck+, cca2+ and ccl-.
  • Acción
    SenDx Medical sent Customers notification letters dated January 30th, 2012, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. We have recently become aware of a possible condition in a limited number of ABLBO FLEX analyzers configured with a specific Control PCe lerinted Circuit Board), which can cause the analyzer to report values outside the published performance specifications for pH, pCOz, cNa*, cK*, cCa2* and cCl-. Customers were instructed to immediately implement Alternative 1 or 2 until the signal data PCB is replaced. Alterative I: Stop the use of all affected analyzers until corrective actions can be performed on these analyzers. Alternative 2: Verify proper function of the affected analyzers immediately following every patient sample measurement by measuring a manual QC sample. Customers were asked to complete the fax form acknowledging receipt of the notice and provided a contact for Technical Support at 1-800-736-0600 opt.4.

Device

Device Recall SenDx Medical Inc. ABL80FLEX
  • Modelo / Serial
    Model number: 393-839 Serial number(s): 304157, 304160 and 304162 to 305414 for ABL80 FLEX analyzers
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    One US consignee in state of OH. Other consignees are international such as Australia, France, Netherlands, Denmark, China, United Kingdom, Turkey, Switzerland, Japan, India, Poland, Spain, and Germany. Distribution list submitted with supporting doc.s
  • Descripción del producto
    SenDx Medical Inc || ABL80FLEX || Blood Gas, pH, Electrolyte, and Metabolite System || The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
  • Manufacturer
    Sendx Medical Inc

Manufacturer

Sendx Medical Inc
  • Dirección del fabricante
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92011-1300
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA